Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-04 @ 12:36 AM
Study NCT ID:
NCT03587168
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2018-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2018-07-03', 'studyFirstSubmitQcDate': '2018-07-13', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The timed 360° turn test', 'timeFrame': '10 seconds', 'description': 'Turning ability is assessed by using the timed 360° turn test. In the timed 360° turn test, a piece of colored tape is placed on the floor to mark the starting position. Each subject was required to stand with arms by his/her side and feet comfortably apart and pointing to the tape. Timing was started from the word "go" and stopped when subject\'s shoulders were facing forward again. The time taken to complete the turn was recorded (in seconds) by a stopwatch.'}], 'secondaryOutcomes': [{'measure': 'Berg Balance Scale', 'timeFrame': '15 minutes', 'description': 'Functional balance is assessed by using the Berg Balance Scale. During the test, participants are asked to perform 14 tasks frequently used in daily life activities. Each item is scored between 0 (unable to perform the task) and 4 (task is performed independently) according to the ability of the person while performing the task. The highest possible score is 56 points. A higher score indicates better balance.'}, {'measure': 'Trunk Impairment Scale', 'timeFrame': '20 minutes', 'description': 'Trunk performance is assessed by using the trunk impairment scale. The Trunk Impairment Scale consists of three subscales: static sitting balance, dynamic sitting balance and co-ordination. A higher score indicating a better performance.'}, {'measure': 'Functional Reach Test', 'timeFrame': '15 seconds', 'description': 'The Functional Reach Test assesses balance by measuring the limits while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.'}, {'measure': 'Four Square Step Test', 'timeFrame': '15 seconds', 'description': "The Four Square Step Test measures dynamic balance and clinically assesses the person's ability to step over objects forward, sideways, and backward. A square was formed by 4 canes resting flat on the floor. The participants were instructed to try and complete the sequence as fast as possible without touching the canes with both feet, making contact with the floor in each square."}, {'measure': 'Timed Up and Go Test', 'timeFrame': '10 seconds', 'description': 'Functional mobility is assessed by using the timed up and go test. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.'}, {'measure': 'Hoehn and Yahr Scale', 'timeFrame': '1 minutes', 'description': "Disease stage is assessed by the Hoehn and Yahr Scale. The Hoehn and Yahr scale is a commonly used diagnostic tool for quantifying the progression of Parkinson's Disease symptoms. Stages range from 0 (no signs of disease) to 5 (requiring a wheelchair, or bedridden unless assisted)."}, {'measure': "Unified Parkinson's Disease Rating Scale", 'timeFrame': '15 minutes', 'description': "The Unified Parkinson's Disease Rating Scale is increasingly used as a gold standard reference scale and includes four components (Part I, Mentation, Behavior and Mood; Part II, Activities of Daily Living; Part III, Motor;Part IV, Complications). A lower score indicates lower disease severity."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'The Timed 360° Turn Test', 'Validity', 'Reliability'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '8996460', 'type': 'BACKGROUND', 'citation': "Schenkman M, Cutson TM, Kuchibhatla M, Chandler J, Pieper C. Reliability of impairment and physical performance measures for persons with Parkinson's disease. Phys Ther. 1997 Jan;77(1):19-27. doi: 10.1093/ptj/77.1.19."}, {'pmid': '18608364', 'type': 'BACKGROUND', 'citation': "Stack E, Ashburn A. Dysfunctional turning in Parkinson's disease. Disabil Rehabil. 2008;30(16):1222-9. doi: 10.1080/09638280701829938."}, {'pmid': '24880056', 'type': 'BACKGROUND', 'citation': 'Kluger BM, Brown RP, Aerts S, Schenkman M. Determinants of objectively measured physical functional performance in early to mid-stage Parkinson disease. PM R. 2014 Nov;6(11):992-8. doi: 10.1016/j.pmrj.2014.05.013. Epub 2014 May 28.'}, {'pmid': '16338159', 'type': 'BACKGROUND', 'citation': "Stack EL, Ashburn AM, Jupp KE. Strategies used by people with Parkinson's disease who report difficulty turning. Parkinsonism Relat Disord. 2006 Mar;12(2):87-92. doi: 10.1016/j.parkreldis.2005.08.008. Epub 2005 Dec 9."}, {'pmid': '26694578', 'type': 'BACKGROUND', 'citation': 'Shiu CH, Ng SS, Kwong PW, Liu TW, Tam EW, Fong SS. Timed 360 degrees Turn Test for Assessing People With Chronic Stroke. Arch Phys Med Rehabil. 2016 Apr;97(4):536-544. doi: 10.1016/j.apmr.2015.11.010. Epub 2015 Dec 13.'}, {'pmid': '1736161', 'type': 'BACKGROUND', 'citation': "Giladi N, McMahon D, Przedborski S, Flaster E, Guillory S, Kostic V, Fahn S. Motor blocks in Parkinson's disease. Neurology. 1992 Feb;42(2):333-9. doi: 10.1212/wnl.42.2.333."}]}, 'descriptionModule': {'briefSummary': "Difficulty in turning is common after Parkinson's Disease. Patients with Parkinson's Disease take a greater number of steps, longer duration, narrower base of support in turning. Thus, turning ability is systematically investigated in Parkinson's Disease. The aim of this study to invastigate reliability, validity, and responsiveness of the timed 360° turn test in Patients with Parkinson's Disease.", 'detailedDescription': 'At baseline, the timed 360° turn test, Unified Parkinson\'s Disease Rating Scale, Hoehn and Yahr Scale, Berg Balance Scale, Functional Reach Test, Timed Up and Go Test, Four Square Step Test and Trunk Impairment Scale was applied to the patients with Parkinson\'s Disease when the patients were "on" period. The timed 360° turn test was repeated after seven days from the first application when patients with Parkinson\'s Disease were "on" period to evaluate its reliability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Parkinson's Disease who apply to the Gazi University, Department of Physiotherapy and Rehabilitation will be invited to this study.", 'eligibilityCriteria': "Inclusion Criteria:\n\n* at least 40 years of age,\n* neurologist-diagnosed Parkinson's Disease\n* Hoehn \\& Yahr (H\\&Y) stages 1 to 4,\n* were able to walk 10 m with or without aids\n\nExclusion Criteria:\n\n* visual, auditory, and orientational problems affecting study results\n* orthopedic problems affecting walking,\n* other neurologic conditions, cardiovascular, musculuskeletal, and vestibular disease"}, 'identificationModule': {'nctId': 'NCT03587168', 'briefTitle': "The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Gazi University'}, 'officialTitle': "The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '441'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients with Parkinson's Disease", 'description': "Patients with Parkinson's Disease Parkinson's Disease (Hoehn and Yahr stage 1-4)", 'interventionNames': ['Other: the timed 360° turn test', 'Other: Berg Balance Scale', 'Other: Four Square Step Test', 'Other: Functional Reach Test', 'Other: Trunk Impairment Scale', 'Other: Timed Up and Go Test', 'Other: Hoehn and Yahr Scale', "Other: Unified Parkinson's Disease Rating Scale"]}, {'label': 'Healthy Controls', 'description': 'Healthy People', 'interventionNames': ['Other: the timed 360° turn test']}], 'interventions': [{'name': 'the timed 360° turn test', 'type': 'OTHER', 'description': 'Turning ability is assessed by using the timed 360° turn test.', 'armGroupLabels': ['Healthy Controls', "Patients with Parkinson's Disease"]}, {'name': 'Berg Balance Scale', 'type': 'OTHER', 'description': 'Functional balance is assessed by using the Berg Balance Scale.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': 'Four Square Step Test', 'type': 'OTHER', 'description': 'The Four Square Step Test measures dynamic balance.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': 'Functional Reach Test', 'type': 'OTHER', 'description': 'The Functional Reach Test assesses limits of stability.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': 'Trunk Impairment Scale', 'type': 'OTHER', 'description': 'Trunk performance is assessed by using the trunk impairment scale.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': 'Timed Up and Go Test', 'type': 'OTHER', 'description': 'Functional mobility is assessed by using the timed up and go test.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': 'Hoehn and Yahr Scale', 'type': 'OTHER', 'description': 'Disease stage is assessed by the Hoehn and Yahr Scale.', 'armGroupLabels': ["Patients with Parkinson's Disease"]}, {'name': "Unified Parkinson's Disease Rating Scale", 'type': 'OTHER', 'description': "The Unified Parkinson's Disease Rating Scale assesses disease severity.", 'armGroupLabels': ["Patients with Parkinson's Disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '06560', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Fatih Söke', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Fatih Söke', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gazi University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gazi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Fatih Söke', 'investigatorAffiliation': 'Gazi University'}}}}